Liu 1995.
Methods | RCT Approved by the ethics committee and informed consent obtained Setting: United States of America Funding: charity (plus a contribution from industry) |
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Participants | 54 ASA 1 to 3 patients undergoing elective partial resection of the colon | |
Interventions |
Treatment group: TEA (T8‐T9 or T9‐T10; catheter threaded 3 cm) with bupivacaine 0.15%, 10 mL/h for various times (n = 14) or combinations of epidural morphine 0.03 mg/mL + bupivacaine 0.1%, 10 mL/h for various times (n = 14)
Control group: postoperative epidural morphine 0.05 mg/mL 10 mL/h for various times (n = 12) Analgesia at rest was titrated to a verbal pain score < 5/10 (0 = no pain, 10 = worst possible pain) with an epidural injection of fentanyl 50 micrograms followed by an increase in the epidural infusion of 2 mL/h every hour as needed. Therefore, all participants received epidural opioids, and the 2 groups with bupivacaine were fused to be compared with the control group Length of epidural infusion taken as ≥ 48 hours, although not clearly stipulated |
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Outcomes | Time of first flatus VAS scores at movement at 24, 48 and 72 hours Hospital LOS Anastomotic leakage |
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Notes | One group with postoperative IV PCA morphine not retained for analysis Groups B and MB were ready for discharge an average of 35 hours earlier (95% confidence interval for difference ranges from 27 to 49 hours) than groups M and P |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Separate randomization tables were prepared for each institution. Randomization was stratified by planned left vs right colonic anastomosis because left colonic anastomosis may result in greater postoperative ileus |
Allocation concealment (selection bias) | Unclear risk | Unclear (randomized on arrival to the preoperative holding area) |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Epidural groups (MB, M and B) were double‐blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Epidural groups (MB, M and B) were double‐blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No other loss to follow‐up (apart from the 2 withdrawn because a catheter could not be inserted) |
Selective reporting (reporting bias) | Low risk | All results reported |
Other bias | Unclear risk | Groups well balanced Not in intention‐to‐treat: Epidural catheters could not be placed in 2 participants, who were withdrawn from the protocol |